GVP Module IX: Signal Management

An agency of the European Union Presented by: Agnieszka Szmigiel Pharmacovigilance and Risk Management Sector, EMA GVP Module IX: Signal Management 19 April 2012 SME Workshop Focus on Pharmacovigilance GVP Module IX: Signal Management 1 Background Sections of GVP Module IX Signal Management definitions steps Work sharing for data monitoring in EudraVigilance (EV)* Periodicity of data monitoring in EV* MAHs obligations Role of Pharmacovigilance Risk Assessment Committee (PRAC) Tracking Improvements Topics * Applicable for the European Medicines Agency and the National Competent Authorities GVP Module IX: Signal Management 2 Background 5% of all hospital admissions are due to an ADR 5% of all hospital patients suffer an ADR ADRs are the 5th most common cause of hospital death. It is estimated that 197,000 deaths per year in the EU are caused by ADRs The total cost to society of ADRs in the EU is 79 billion.

5 GVP Module IX: Signal Management Signal Management (SM) is a set of activities to determine based on various data sources* whether there are new/changed risks associated with active substances/medicinal products: SM steps: – Signal detection, – Signal validation (and confirmation), – Prioritisation, analysis and assessment,

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  Management, Signal, Detection, Signal management, Signal detection, Signal management signal management

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